Pemetrexed medac

Do not take it if

From the package leaflet in EMA’s product information, p. 36.

How to take it

These directions are for this exact strength and form. Another one is different.

• The recommend dose of Pemetrexed medac is 500 mg for every square metre of your body’s surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dose may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition. A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed medac powder with 9 mg/ml (0.9 %)
• sodium chloride solution for injection before it is given to you.
• You will always receive Pemetrexed medac by infusion into one of your veins. The infusion will last approximately 10 minutes.
• When using Pemetrexed medac in combination with cisplatin The doctor or hospital pharmacist will work out the dose you need based on your height and weight.
• Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed medac has finished. The infusion of cisplatin will last approximately 2 hours.
• You should usually receive your infusion once every 3 weeks.
• Additional medicines Corticosteroids Your doctor will prescribe you steroid tablets (equivalent to 4 mg of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed medac treatment.
• This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
• Vitamin supplementation Your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 – 1,000 μg) that you must take once a day while you are taking Pemetrexed medac. You must take at least 5 doses during the seven days before the first dose of Pemetrexed medac. You must continue taking the folic acid for 21 days after the last dose of Pemetrexed medac. You will also receive an injection of Vitamin B (1,000 μg) in the week before administration of Pemetrexed medac and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed medac treatment).
• Vitamin B and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 38.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 37.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 37.

Other medicines

From the package leaflet in EMA’s product information, p. 37.

Driving and using machines

• Pemetrexed medac may make you feel tired. Be careful when driving a car or using machines.
• Pemetrexed medac contains sodium Pemetrexed medac 100 mg This medicine contains less than 1 mmol sodium (23 mg) per 100 mg vial, that is to say essentially ‘sodium-free’.
• Pemetrexed medac 500 mg This medicine contains 54 mg sodium (main component of cooking/table salt) in each 500 mg vial.
• This is equivalent to 2.70% of the recommended maximum daily dietary intake of sodium for an adult.
• Pemetrexed medac 1,000 mg This medicine contains 108 mg sodium (main component of cooking/table salt) in each 1,000 mg vial.
• This is equivalent to 5.40% of the recommended maximum daily dietary intake of sodium for an adult.

From the package leaflet in EMA’s product information, p. 38.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• You must contact your doctor immediately if you notice any of the following:
• − fever or infection (respectively, common or very common): if you have a temperature of 38 °C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common). Infection (sepsis) may be severe and could lead to death.
• − if you start feeling chest pain (common) or having a fast heart rate (uncommon)
• − if you have pain, redness, swelling or sores in your mouth (very common)
• − allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common). Rarely, skin reactions may be severe and could lead to death.
• Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis)
• − if you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common)
• − if you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is common)
• − if you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon) (may indicate a blood clot in the blood vessels of the lungs)
• The following side effects can occur during treatment with pemetrexed:
• Very common (may affect more than 1 in 10 people)
• Infection Pharyngitis (a sore throat)
• Low number of neutrophil granulocytes (a type of white blood cell)
• Low white blood cells Low haemoglobin level Pain, redness, swelling or sores in your mouth Loss of appetite Vomiting Diarrhoea Nausea Skin rash Flaking skin Abnormal blood tests showing reduced functionality of kidneys Fatigue (tiredness)
• Common (may affect up to 1 in 10 people)
• Blood infection Fever with low number of neutrophil granulocytes (a type of white blood cell)
• Low platelet count Allergic reaction Loss of body fluids Taste change Damage to the motor nerves which may cause muscle weakness and atrophy (wasting) primary in the arms and legs)
• Damage to the sensory nerves that may cause lost of sensation, burning pain and unsteady gait Dizziness Inflammation or swelling of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye Dry eye Watery eyes Dryness of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye) and cornea (the clear layer in front of the iris and pupil.
• Swelling of the eyelids Eye disorder with dryness, tearing, irritation, and/or pain Cardiac Failure (Condition that affects the pumping power of your heart muscles)
• Irregular heart rhythm Indigestion Constipation Abdominal pain Liver: increases in the chemicals in the blood made by the liver Increased skin pigmentation Itchy skin Rash on the body where each mark resembles a bullseye Hair loss Hives Kidney stop working Reduced functionality of kidney Fever Pain Excess fluid in body tissue, causing swelling Chest pain Inflammation and ulceration of the mucous membranes lining the digestive tract Uncommon (may affect up to 1 in 100 people)
• Reduction in the number of red, white blood cells and platelets Stroke Type of stroke when an artery to the brain is blocked Bleeding inside the skull Angina (Chest pain caused by reduced blood flow to the heart)
• Heart attack Narrowing or blockage of the coronary arteries Increased heart rhythm Deficient blood distribution to the limbs Blockage in one of the pulmonary arteries in your lungs Inflammation and scarring of the lining of the lungs with breathing problems Passage of bright red blood from the anus Bleeding in the gastrointestinal tract Ruptured bowel Inflammation of the lining of the oesophagus Inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding (seen only in combination with cisplatin)
• Inflammation, edema, erythema, and erosion of the mucosal surface of the esophagus caused by radiation therapy Inflammation of the lung caused by radiation therapy Rare (may affect up to 1 in 1,000 people)
• Destruction of red blood cells Anaphylactic shock (severe allergic reaction)
• Inflammatory condition of the liver Redness of the skin Skin rash that develops throughout a previously irradiated area Very rare (affect up to 1 of 10 000 people)
• Infections of skin and soft tissues Stevens-Johnson syndrome (a type of severe skin and mucous membranes reaction that may be life threatening)
• Toxic epidermal necrolysis (a type of severe skin reaction that may be life threatening)
• Autoimmune disorder that results in skin rashes and blistering on the legs, arms, and abdomen Inflammation of the skin characterized by the presence of bullae which are filled with fluid Skin fragility, blisters and erosions and skin scarring Redness, pain and swelling mainly of the lower limbs Inflammation of the skin and fat beneath the skin (pseudocellulitis)
• Inflammation of the skin (dermatitis)
• Skin to become inflamed, itchy, red, cracked, and rough Intensely itchy spots Not known (frequency cannot be estimated from the available data)
• Form of diabetes primarily due to pathology of the kidney Disorder of the kidneys involving the death of tubular epithelial cells that form the renal tubules Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 39–41.

How to store it

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
• This medicine does not require any special storage conditions.
• Reconstituted and infusion solutions: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature (2 °C – 8 °C).
• This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.

From the package leaflet in EMA’s product information, p. 41.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

• The other ingredients are mannitol, hydrochloric acid and sodium hydroxide, please see section 2 “Pemetrexed medac contains sodium”.
• What Pemetrexed medac looks like and contents of the pack Pemetrexed medac is a powder for concentrate for solution for infusion in a glass vial with rubber stopper.

From the package leaflet in EMA’s product information, p. 41.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Pemetrexed